Safety evaluation of long-term intake of drink containing plant-derived anthocyanin for healthy adults or subjects with high normal liver function

Safety evaluation of long-term intake of drink containing plant-derived anthocyanin for healthy adults or subjects with high normal liver function - Safety evaluation of long-term intake of drink containing plant-derived anthocyanin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028275

Enrollment

Registered

2017-07-18

Start date

2017-07-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult

Interventions

Intake of drink containing plant-derived anthocyanin, quantity of recommended daily intake, for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Males and females from 20 to 64 years of age (2) The liver function test value at the time of preliminary examination corresponds to the normal range or health guidance judgment value, and subjects who judged by a healthy person and a doctor from other inspection results A. Subjects who satisfy all conditions of ALT 30 U/L or less, AST 30 U/L or less and gamma-GT 50 U/L or less (10 subjects) B. Subjects who satisfy under at least one of the conditions of ALT 31 U/L or more, AST 31 U/L or more, or gamma-GT 51 U/L or more (10 subjects)

Exclusion criteria

Exclusion criteria: (1) Subjects who constantly use health food richly containing involvement ingredient (2) Subjects who constantly use supplements or drugs affecting the liver function (3) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (4) Subjects having possibilities for emerging allergy related to the study (5) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (6) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (7) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (8) Subjects who intend to become pregnant or lactating (9) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (10) Subjects judged as unsuitable for the study by the investigator for other reasons

Design outcomes

Primary

Measure	Time frame
Hematologic test, Blood biochemistry test, Urine test, Blood pressure/pulsation, Weight/body mass index, Medical Interview, before and 4, 8, 12 weeks after intake and 4 weeks after the end of intake period and Adverse events thorough the study	—

Countries

Japan

Contacts

Public ContactShinsuke Tsuji

TTC CO., LTD. Clinical Research Planning Department

s.tsuji@ttc-tokyo.co.jp03-5459-5329

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026